Memory’s Drug Fails IIa Trial in Bipolar Disorder

Memory Pharmaceuticals’ Phase IIa study of MEM 1003 in acute mania in bipolar disorder, based on primary and secondary outcome measures in the trial, did not prove effective.

The multi-center, double-blind, randomized, placebo-controlled study evaluated the safety and efficacy of MEM 1003 for the treatment of acute mania in bipolar disorder in 84 subjects. The primary outcome measure was a comparison of the percentage of subjects in the placebo and MEM 1003 treatment groups with at least 50% improvement from baseline in the Young Mania Rating Scale (YMRS) at 21 days. The secondary outcome measures were the mean change from baseline in the YMRS, the Modified Clinical Global Impression – Bipolar Scale and the Montgomery-Asberg Depression Rating Scale at 21 days. None of these outcome measures was achieved.

MEM 1003 was safe and generally well-tolerated in the study. There were no serious adverse events reported in the MEM 1003 treatment group during the study, in contrast to three serious adverse events of worsening of mania reported in the placebo treatment group.

“We are obviously disappointed that MEM 1003 did not prove effective in the treatment of mania in our study,” said Stephen R. Murray, M.D., Ph.D., vice president of clinical development. “However, the target symptoms and the nature of the assessments in our ongoing Phase IIa study in Alzheimer’s disease are very different from those in this mania study, and we do not believe that the negative results in this study are predictive of the effects of MEM 1003 in Alzheimer’s disease.

“We are committed to finishing the ongoing Phase IIa study in Alzheimer’s disease and expect results in the fourth quarter of this year,” said David A. Lowe, Ph.D., chief scientific officer. “We are currently completing a full analysis of the bipolar results in order to learn as much as we can from this data set.”